MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-10 for VAC-PAC 51630 manufactured by Natus Medical Incorporated.
[108619660]
A visual product examination discovered that the size and lot number labels were missing on the device. An id tag had been attached by wire to the valve, and the surface had markings and residue from adhesive. Further examination confirmed a low bead fill, and the vac-pac seemed flat. One protrusion was found in the fabric (0. 2 cm x 0. 3 cm). A 0. 1 cm scrape, 3. 6 cm from the seam, was also found. The vac-pac lost its vacuum and softened after 24 hours of lying flat, suctioned and firm. The aforementioned scrape was found to be a pinhole after testing.
Patient Sequence No: 1, Text Type: N, H10
[108619661]
On (b)(6) 2018, a natus technical service representative (tsr) received an e-mail from a distributor ((b)(4)) which described that a customer ((b)(6) hospital) reported a vac-pac device failure during surgery. The vac-pac was purchased in (b)(6) 2017. The report noted that during surgery, a fixing failure was found, so the customer replaced the vac-pac with another unit. The distributor reported that they tested the suspect vac-pac and it became loose after 20 minutes. The distributor noted they could not find the leak in the vac-pac and that "the suction seemed a little crushed. " on (b)(6) 2018, the distributor reported that there were no problems during surgery. The distributor also mentioned that they are unable to obtain patient information. The tsr asked if this was an out of box failure and also requested the distributor return this vac-pac to natus medical for evaluation. On (b)(6) 2017, the distributor reported that this was an out of box failure, and the vac-pac was received for evaluation on (b)(6) 2018. No death, serious injury, patient harm or environmental/safety concerns have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00122 |
| MDR Report Key | 7505103 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-10 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-04-06 |
| Date Mfgr Received | 2018-04-12 |
| Date Added to Maude | 2018-05-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685133 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAC-PAC |
| Generic Name | VAC-PAC |
| Product Code | CCX |
| Date Received | 2018-05-10 |
| Returned To Mfg | 2018-05-03 |
| Model Number | 51630 |
| Lot Number | N112216-15 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-10 |